This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Hemodynamic Changes in Connective Tissue Disease

This study has been completed.
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: November 7, 2011
Last updated: February 18, 2014
Last verified: February 2014
The study serves the identification of early forms of pulmonary arterial hypertension (PAH) in connective tissue disease and the hemodynamic follow-up of the investigated patients. The basic hypothesis is that PAH may start with a remodeling of small pulmonary arteries, which leads to a stiffening of the vessels, indicated by the inability to vasodilatation and thus a disproportional increase in pulmonary pressure during exercise. Recent studies have shown that a proportion of such patients may develop manifest PAH within a few years. The early identification of these patients and the understanding of the natural course of the disease may improve prognosis. The aim of the present study is to investigate hemodynamic and clinical changes in patients with connective tissue disease in a time interval of 3-5 years with a focus on the development of pulmonary hypertension.

Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemodynamic Changes in Connective Tissue Disease

Resource links provided by NLM:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • systolic pulmonary pressure at 50 W [ Time Frame: 3-5 years ]
    change of systolic pulmonary arterial pressure after 3-5 years

Secondary Outcome Measures:
  • peak (oxygen uptake) VO2 [ Time Frame: 3-5 years ]
    change of peak VO2 after 3-5 years

Enrollment: 85
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with known systemic sclerosis and without known pulmonary hypertension

Inclusion Criteria:

  • Informed consent
  • Patients with systemic sclerosis, mixed connective tissue disease, (systemic lupus erythematodes) SLE or overlap syndrome
  • Existing exercise Doppler echocardiography or/and right heart catheterization 3-5 years before inclusion

Exclusion Criteria:

  • - Severe lung or bronchial disease (FEV1 <60%)
  • Systolic LV dysfunction (LVEF <50%) or diastolic dysfunction > grade I
  • Valvular defect > grade I (except for tricuspid- or pulmonary insufficiency)
  • Uncontrolled systemic arterial hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
  • Uncontrolled ventricular arrhythmias
  • Uncontrolled bradycardia or tachycardia supraventricular arrhythmias
  • Myocardial infarction within the last 12 months
  • Pulmonary embolism within the last 12 months
  • Relevant changes in hemodynamic therapy or major surgery within the last 12 weeks
  • Musculoskeletal or peripheral vessel disorders which complicates an ergometry
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01468792

Medical University of Graz / Pulmonology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

Responsible Party: Medical University of Graz Identifier: NCT01468792     History of Changes
Other Study ID Numbers: 23-409 ex 10/11
23-409 ex 10/11 ( Other Grant/Funding Number: MUG )
Study First Received: November 7, 2011
Last Updated: February 18, 2014

Keywords provided by Medical University of Graz:
systemic sclerosis
pulmonary arterial hypertension

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Pathologic Processes
Skin Diseases processed this record on September 25, 2017